Ideas and Insight supporting all stages of Drug Discovery & Development

On January 2, 2020, the FDA released the CDER annual report, stating that 2019 was “another strong year for innovation and advances.” The FDA cleared 48 new drugs for market, making it the second most productive year in the last decade (2018 approved 59 drugs). But given the fact that the total number of submissions have gone down, and that the American government was shut down for a lengthy period at the beginning of the year, the FDA delivered an impressive result in 2019.

For decades, aspirin (acetylsalicylic acid) has been viewed
as something of a wonder drug. A staple in most households, people have turned
to it for everything from headache relief to heart attack prevention. However,
recent studies have raised some serious questions about the benefits of regular
aspirin usage.

A leading cause of attrition of compounds in drug
development, drug-induced liver injury (DILI) is also one of the top causes of
drug withdrawals, restrictions and project terminations. DILI results when
reactive metabolites – formed when certain orally administered drugs are
metabolized in the liver – end up binding to cellular proteins and damaging
liver cells.

The partial shutdown of the U.S. government, which began just before the Christmas holiday, has been especially terrible for hundreds of thousands of federal employees who are either furloughed or working without pay. (more…)